Double-Blind, Placebo-Controlled Comparative Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between Hour 3 and Hour 24 of system application
研究概览
简要总结
This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected to require opioid analgesia for management of post-operative pain for at least 24 hours after surgery and require postoperative pain control
- •Underwent one of the following surgeries under general anesthesia:
- •Abdominal surgery (e.g., gastrointestinal, gynecological)
- •Orthopedic surgery (e.g., spinal surgery)
- •Thoracic surgery (e.g., respiratory surgery not requiring chest tubes after surgery)
- •ASA physical status I, II or III
- •Age: At least 20 years
- •Sex: Men or women (negative pregnancy test for women of childbearing potential).
- •Inpatient/outpatient status: Inpatient
- •Received adequate information about the study and gave a written consent to participate in the study by himself/herself
排除标准
- •Expected to use continuous intra-operative and post-operative analgesia with local pain control techniques (e.g., spinal/epidural analgesia, nerve block)
- •Scheduled for body surface surgery (e.g., burn, breast reconstruction, skin grafting)
- •Hypersensitive/allergic to fentanyl, skin adhesive and/or cetylpyridinium chloride
- •Expected/scheduled to undergo additional surgical procedure within 36 hours post-operation
- •Known or suspected opioid tolerance
- •Skin disorder that precludes application of investigational product
- •Increased intracranial pressure
- •Concomitant asthma, severe respiratory disorder
- •Having had convulsive seizure attacks within 5 years
- •Patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators
- •History of opioid, drug and/or alcohol abuse
- •Women who are pregnant, might be pregnant, or are breastfeeding
- •Using any investigational drug, used any investigational drug within the last 6 months
- •Otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator
研究组 & 干预措施
SyB P-1501 group
One patch of SyB P-1501 contains 10.8 mg of fentanyl hydrochloride (fentanyl 9.7 mg) and produces an electric current to deliver the drug iontophoretically after the system is activated. 40 µg fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours or maximum of 80 doses. Each system will inactivate at 80 doses or 24 hours, whichever occurs first.
干预措施: SyB P-1501 (Drug)
SyB P-1501 placebo group
Identical to SyB P-1501 containing hydrogel that contains the active ingredient fentanyl HCI in its structure and appearance but production of an electric current and subsequent drug administration by iontophoresis are prevented because of its modified circuit.
干预措施: SyB P-1501 placebo (Drug)
结局指标
主要结局
Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between Hour 3 and Hour 24 of system application
时间窗: 3 to 24 hours
proportion of dropouts due to inadequate analgesia during the period between Hour 3 and Hour 24 of system application. Inadequate analgesia cases are defined below. * The subject wishes to discontinue the study due to inadequate analgesia * Investigator or sub-investigator judges that the patient is to be discontinued due to inadequate analgesia * The subject who completes 80 doses within 24 hours is not willing to use the second system and wishes an alternative analgesia
次要结局
- incidence of technical failures defined as unfavorable conditions concerned with such as quality, safety, or performance of mechanic parts of investigational products(20 days)
- Proportion of dropouts due to inadequate analgesia judged by patients or investigator during the period between the start and Hour 24 of system application(0 to 24 hours)
- Proportion of dropouts for any reason during the period between Hour 3 and Hour 24 of system application or between the system application and Hour 24(0 to 24 hours)
- Patient global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups(0 to 24 hours)
- Investigator global assessment of method of Pain Control compared using Wilcoxon two sample test or Fisher's exact test between groups(0 to 24 hours)
- time to dropout during the period between Hour 3 and Hour 24 of system application (Non-dropout: censored at 24 hours after application) or from application (Non-dropout: censored at 24 hours after application)(0 to 24 hours)
- pain intensity（Numerical rating scale: NRS） expressed as a mean for each group and compared using Student t test between groups(0 to 72 hours)
- Adverse events (including application site erythema and other application site reactions) coded with MedDRA and graded for severity at three level(20 days)
- Changes in the measurements of vital signs (blood pressure, heart rate, respiratory function, SpO2) and laboratory tests (hematological test and blood biochemical test) measured with descriptive statistics(20 days)